1. Field of the Invention
The invention relates to systems for the irrigation and/or aspiration of fluids into or from a surgical work site during an endoscopic procedure. More particularly, the invention relates to a multi-purpose irrigation/aspiration system for use during minimally invasive surgery for the purpose of performing any one of a variety of irrigation/aspiration functions such as, for example, tissue lavage, joint distension or uterine distension.
2. Description of the Prior Art
Minimally invasive surgery, also referred to herein as endoscopic surgery, often utilizes an irrigation system to force suitable biocompatible fluid into the area surrounding the surgical work site within a patient. The term "irrigation" is used broadly to mean any type of pressurized fluid flow whether it be for irrigation in particular or other uses described below. Flexible plastic tubing is used to conduct the fluid from a source to the work site and from the work site to a drain or other receptacle. Flexible tubing is also sometimes used as a pressure monitoring line to convey fluid pressure information to a control mechanism. Depending upon the procedure, the irrigating fluid is useful for various purposes such as tissue lavage, hydro-dissection, joint distension, uterine distension, etc. Known irrigation systems include electrically driven pump systems, in which a suitable fluid is pumped through flexible tubes from a source to the work site, gravity-feed systems in which the pump is replaced by merely adjusting the height of the fluid supply above the patient and nitrogen powered systems.
Known aspiration systems employ any source of reduced-pressure (i.e. lower than that of the work site) and include vacuum systems, in which a vacuum source is simply connected via flexible tubes to the work site, and simple gravity controlled drain lines. Aspiration of the fluid serves to either simply remove it to prevent undesirable accumulation or high pressure at the work site, or to regulate the flow rate to maintain a predetermined fluid pressure at the work site.
Because the irrigation and aspiration functions are commonly used together, prior art irrigation/aspiration systems have been developed to perform both functions with one system, often combined in one console. The irrigation system is generally used in conjunction with an aspiration system which removes the fluid pumped into the work site at a controlled rate depending on the flow rate selected by the surgeon. Each system utilizes a collection of flexible tubes to connect the fluid and vacuum sources to appropriate instruments inserted into the body. The collection of tubes includes a fluid inflow conduit, a fluid outflow conduit and, in some instances, a pressure monitoring conduit. All of the tubes are packaged together as a tubing set and each tubing set is produced as a unit containing all necessary tubes and connections required for performing a particular procedure with a particular system.
Some prior art irrigation/aspiration systems and tubing sets required considerable effort on the part of the operating room staff in order to hook-up the tubing set to the system and the patient. Consequently, disposable cartridges or cassette tubing sets have been developed for certain irrigation/aspiration systems.
For example, the Intelijet.TM. Arthroscopic Fluid Management System marketed by Dyonics utilizes a disposable tubing cassette adapted to engage and be operated by a control console. This cassette is formed of two flat mating halves which, when secured together, form a housing which contains two molded conduits, one of which contains a silicone tube. The ends of each conduit are adapted to be connected to the ends of external PVC tubes. The housing also contains an impeller which is rotated by a corresponding drive member in the console when the cassette is properly placed and, in one of the conduits, a membrane in the inflow line for use with a pressure transducer on the console. This cassette requires that at least four separate tubes be connected to their respective portals in the cassette housing.
Similar tubing cassettes are also known in ocular surgical irrigation/aspiration pumps such as described in U.S. Pat. No. 4,713,051 (Steppe et al.). This cassette is a flat housing having top and bottom mating portions which enclose an intermediate portion of an irrigation conduit and an intermediate portion of an aspiration conduit. The housing includes a pressure or vacuum sensing line and is designed to be plugged into a system console which provides power and control for irrigation and aspiration functions.
While these cassettes simplify set-up of the systems, they are somewhat complex and the systems are not single irrigation/aspiration systems capable of automatically performing more than one dedicated function. Prior art procedures often involve the use of a separate irrigation/aspiration system for a single type of endoscopic procedure because the various operating characteristics (pressure, flow rate, etc.) required of an irrigation/aspiration system intended for use with different procedures depend upon the procedure and the portion of the body involved. Thus, a hysteroscopic irrigation system is used for hysteroscopic procedures, an arthroscopic irrigation system is used for arthroscopic procedures and a laparoscopic irrigation system is used for laparoscopic procedures. Each individual procedure incorporates the use of specific tubing sets designed to work with a particular irrigation/aspiration system and to perform specific functions uniquely tailored for that procedure in order to connect the irrigation/aspiration system to the particular work site.
For hysteroscopic and arthroscopic procedures the prior art systems deliver fluid to the joint or the uterus for the purpose of controlled distension for clearing debris and improved visualization. Hysteroscopic and arthroscopic systems are commonly used with one or more cannulae to provide the functions of fluid inflow, aspiration and pressure monitoring. The output pressure is adjustable in these units and there is, therefore, some control over the use of the system. However, there is no known system which automatically adjusts the pressure limit available for use with a particular tubing set.
For laparoscopic procedures the prior art systems deliver fluid to the body cavity for the purpose of flushing blood or debris from the organ or for hydrodissection of tissue. The irrigation systems used in laparoscopic procedures are to be distinguished from insufflation systems intended for distension of the body cavity. Laparoscopic systems commonly employ a hand-held irrigation/aspiration probe which is provided with a multi-ported trumpet valve or the like to enable the user to select either irrigation or aspiration.
In the interest of optimizing use of equipment and space in operating rooms, it is desirable to have a single irrigation/aspiration system suitable for performing a variety of surgical procedures. One such system is described in U.S. Pat. No. 5,246,422 (Favre) in the form of a console which is capable of receiving any of a variety of tubing cassettes, each dedicated for a specific procedure. Each cassette houses a pair of peristaltic pumps and inflow and outflow tubes associated with the pumps. Each cassette also carries a stem extending from one side at a particular position which depends upon the procedure for which the cassette is intended. A plurality of detectors is situated on the console to detect the stem and each detector is associated with a particular program for operating the system as a function of the procedure for which the cassette is intended. This system utilizes a flat, two-sided cassette housing similar to the previously described cassettes. Furthermore, the coding device (i.e. stem) used in this system requires a different cassette housing for each type of tubing cassette. That is, the stem position of an arthroscopic cassette is physically different than that of a hysteroscopic cassette. It would be desirable to have an irrigation/aspiration system suitable for use with a variety of identically shaped tubing cassettes, each cassette coded appropriately for a particular procedure without the necessity for producing a different housing for each procedure.
Consequently, it is an object of this invention to produce an irrigation/aspiration system having a single inflow pump and a control system for operating the pump in accordance with predetermined characteristics defined for use during a selected one of several different surgical procedures.
It is also an object of this invention to produce a multi-purpose irrigation/aspiration system capable of operating with a variety of specific types of tubing sets, each set intended for use only during a particular type of surgical procedure.
It is also an object of this invention to produce a multi-purpose irrigation/aspiration system capable of operating with a variety of specific types of tubing sets which are each identified with a particular coding means associated with that tubing set type to identify the use for which the tubing set and/or the system associated therewith is intended.
It is also an object of this invention to produce a group of tubing sets designed to be capable of adapting an irrigation/aspiration system for use in a particular surgical procedure, each set within the group being tailored for and coded for a specific type of surgical procedure.
It is also an object of this invention to produce a tubing cassette for use with a multi-purpose irrigation/aspiration system wherein the cassette facilitates the engagement of the irrigation and aspiration tubing with the system.
It is also an object of this invention to produce a multi-purpose irrigation/aspiration system capable of operating with a variety of specific types of tubing sets which are each identified with a particular coding means associated with that tubing set, the coding means also containing means to automatically initiate a predetermined sequence of initiating steps during the power-on sequence of the system.
It is yet another object of this invention to produce a variety of simplified tubing cassettes for use with a multi-purpose irrigation/aspiration system, each cassette formed from a common housing and uniquely identified with a code identifying the procedure for which the cassette is intended.